ANDA 206039

EXELA PHARMA SCS LLC

FDA Drug Application

Application #206039

Application Sponsors

ANDA 206039

EXELA PHARMA SCS LLC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAMUSCULAR, INTRAVENOUS

5GM/10ML (500MG/ML)

0

MAGNESIUM SULFATE

MAGNESIUM SULFATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-12-18	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-11-27	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	3	Null	7

TE Codes

001

Prescription

AP

CDER Filings

EXELA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206039
            [companyName] => EXELA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MAGNESIUM SULFATE","activeIngredients":"MAGNESIUM SULFATE","strength":"5GM\/10ML (500MG\/ML)","dosageForm":"SOLUTION;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/18\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/27\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-27
        )

)